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Single blinded randomized control study of low-reactive level laser therapy for overactive bladder (LLLT study for overactive bladder)

Single blinded randomized control study of low-reactive level laser therapy for overactive bladder (LLLT study for overactive bladder)

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The average age was 73.9 years in the control group and 72.7 years in the laser group. 5 males and 3 females were enrolled in the control group, and 4 males and 3 females were enrolled in the laser group. There was no significant difference between the two groups in each background factor.

First enrollment: December,2019 Final enrollment: April,2020 Completion: July,2020 Enrollment transition: December,2019 5 patients January ,2020 3 patients February,2020 2 patients March,2020 2 patients April,2020 3 patients One patient in the control group was discontinued because of an adverse event of urinary retention at 12 weeks.

Urinary retention and bloody stool adverse events occurred in one patient in the control group. Both had no causal relationship and were non-serious.

The baseline and week7 changes in urination frequency (primary endpoint) from the bladder diary were 0.3 in the control group and -0.3 in the laser group in the FAS population. The unpaired t-test had a p-value of 0.728, and the analysis of covariance had a p-value of 0.962. Regarding the secondary endpoints, the baseline and week7 changes in the FAS population were as follows: Bladder diary Urinary incontinence frequency: It was 0.0 in the control group and -0.3 in the laser group. The p-value was 0.605 in the unpaired t-test and 0.319 in the analysis of covariance. Urinary urgency frequency: 1.9 in the control group and -4.2 in the laser group. The p-value was 0.002 in the unpaired t-test and 0.001 in the analysis of covariance. Urodynamic study Bladder capacity at the time of initial urination: It was 12.6 in the control group and 78.0 in the laser group. The p-value was 0.146 in the unpaired t-test and 0.169 in the analysis of covariance. Bladder capacity at the time of maximum urination: It was -45.3 in the control group and 215.6 in the laser group. The p-value was 0.006 in the unpaired t-test and 0.007 in the analysis of covariance. Bladder capacity at the time of detrusor overactivity: It was -1.0 in the control group and 74.5 in the laser group. The p-value was 0.041 in the unpaired t-test and 0.014 in the analysis of covariance. Maximum intravesical pressure: It was -2.6 in the control group and -29.5 in the laser group. The p-value was 0.056 in the unpaired t-test and 0.056 in the analysis of covariance. Intravesical pressure at Qmax: It was 3.8 in the control group and -28.2 in the laser group. The p-value was 0.163 in the unpaired t-test and 0.028 in the analysis of covariance. Residual urine: It was -18.8 in the control group and -49.3 in the laser group. The p-value was 0.606 in the unpaired t-test and 0.537 in the analysis of covariance. Maximum flow rate: It was 1.6 in the control group and 3.4 in the laser group. The p-value was 0.668 in the unpaired t-test and 0.443 in the analysis of covariance. AG number: It was -5.7 in the control group and -40.2 in the laser group. The p-value was 0.042 in the unpaired t-test and 0.113 in the analysis of covariance. OABSS OABSS total score: It was 0.4 in the control group and -3.1 in the laser group. The p-value was 0.006 in the unpaired t-test and 0.004 in the analysis of covariance. I-PSS I-PSS total score: It was 1.4 in the control group and -3.6 in the laser group. The p-value was 0.011 in the unpaired t-test and 0.008 in the analysis of covariance. King`s Health Questionnaire Social limitations score: It was -7.9 in the control group and 19.0 in the laser group. The p-value was 0.018 in the unpaired t-test and 0.035 in the analysis of covariance. There were no significant differences in general health score, incontinence impact score, role limitations score, physical limitations score, personal relationships score, emotions score, sleep/energy score, and severity measures score.

The purpose was to evaluate the safety and efficacy of low-reactive level laser therapy of the sacral nerve roots in patients with overactive bladder. There was no significant difference in the urination frequency(primary endpoint). There were significant improvements in urinary urgency, bladder capacity, OABSS, and I-PSS. There were no adverse events in the laser group and there were no safety issues.

Dec. 31, 2021

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190043

Tomoyuki Uchiyama

International university of health and welfare, Ichikawa Hospital

6-1-14 Kounodai Ichikawa-shi Chiba,Japan

tuchiyama@iuhw.ac.jp

Tomoyuki Uchiyama

International university of health and welfare, Ichikawa Hospital

6-1-14 Kounodai Ichikawa-shi Chiba,Japan

+81-47-375-1111

tuchiyama@iuhw.ac.jp

Complete

June. 24, 2019

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

1. Urination frequency is 8 or more times per day on average
2. Falls under any of the following
Urinary incontinence frequency is 1 or more times per day on average
Urinary urgency frequency is 1 or more times per day on average
3. Inadequate or inappropriate effect of behavioral therapy or drug therapy
4. 20 years old and older at IC
5. Outpatient
6. Contraception possible

1. Severe cardiovascular disease
2. Severe liver disease
3. Severe kidney disease
4. Received intervention treatments in other clinical trials within 3 months
5. Pregnant, or have a plan
6. Tattoo, pigmentation, accessories, implantation equipment at the laser irradiation point
7. Malignant tumor
8. Bleeding tendency
9. Physically weak due to aging, disease, etc
10. Treatment of organic disease is prior
11. Urinary output over 3000ml per day
12. Cognitive impairment, mental illness, etc
13. Judged as ineligible by principle investigator or sub investigator

Both

Overactive bladder

[Laser group]
Irradiate the laser to the left and right of the third sacral hole (left: 5 minutes, right: 5 minutes).
Twice a week, and 6 weeks.
[Sham group]
Pretends to irradiate the laser to the left and right of the third sacral hole (left: 5 minutes, right: 5 minutes).
Twice a week, and 6 weeks.

Change in urinary frequency from baseline

1. Bladder diary (urination, urinary incontinence, urine volume, urinary urgency)
2. Urodynamic study
3. IPSS
4. King`s Health Questionnaire
5. OABSS

+81-3-5919-2052

Mar. 20, 2019

none